Dirk Rades1, Jon Cacicedo2, Antonio J Conde-Moreno3, Barbara Segedin4, Jasna But-Hadzic4, Blaz Groselj4, Gvantsa Kevlishvili5, Darejan Lomidze5, Raquel Ciervide-Jurio6, Carmen Rubio6, Luis A Perez-Romasanta7, Ana Alvarez-Gracia8, Denise Olbrich9, Claudia Doemer10, Steven E Schild11, Niels H Hollaender12. 1. Department of Radiation Oncology, University of Lübeck, Luebeck, Germany. Electronic address: Rades.Dirk@gmx.net. 2. Department of Radiation Oncology, Cruces University Hospital, Barakaldo, Vizcaya, Spain. 3. Department of Radiation Oncology, Consorcio Hospital Provincial de Castellon, Castellon, Spain; Department of Radiation Oncology, University and Polytechnic Hospital La Fe, Valencia, Spain. 4. Department of Radiotherapy, Institute of Oncology Ljubljana, Ljubljana, Slovenia. 5. Radiation Oncology Department, University Clinic Tbilisi, Tbilisi, Georgia. 6. Department of Radiation Oncology, University Hospital HM Sanchinarro, Madrid, Spain. 7. Department of Radiation Oncology, University Hospital Salamanca, Salamanca, Spain. 8. Department of Radiation Oncology, ICO - University Hospital Germans Trias i Pujol, Badalona, Spain. 9. Centre for Clinical Trials Lübeck, Luebeck, Germany. 10. Department of Radiation Oncology, University of Lübeck, Luebeck, Germany. 11. Department of Radiation Oncology, Mayo Clinic, Scottsdale, Arizona. 12. Department of Oncology and Palliative Units, Zealand University Hospital, Naestved, Denmark.
Abstract
OBJECTIVE: To investigate precision radiation therapy for metastatic spinal cord compression and compare it to conventional radiation therapy. METHODS AND MATERIALS: In a multicenter phase 2 study, 40 patients received 5 Gy × 5 fractions of precision radiation therapy (38 volume modulated arc therapy, 2 intensity modulated radiation therapy) for metastatic spinal cord compression and were evaluated for local progression-free survival (LPFS), motor function, ambulatory status, sensory function, sphincter dysfunction, pain, distress, overall survival (OS), and toxicity. Maximum spinal cord dose was 101.5% (myelopathy risk, <0.03%) of the prescription dose. Patients were compared with a historical control group conventionally irradiated with 4 Gy × 5 fractions (propensity score analysis). The equivalent dose in 2 Gy-fractions of 5 Gy × 5 fractions is similar to 3 Gy × 10 fractions, which results in better LPFS than 4 Gy × 5 fractions. It was assumed that 5 Gy × 5 fractions is also superior to 4 Gy × 5 fractions for LPFS. (ClinicalTrials.gov-identifier: NCT03070431) RESULTS: Six-month rates of LPFS and OS were 95.0% and 42.6%, respectively. Improvement of motor function occurred in 24 patients (60%). Thirty-three patients (82.5%) were ambulatory after radiation therapy. Eight of 16 patients (50.0%) with sensory deficits improved. Pain and distress relief were reported by 61.9% and 54.2% of patients 1 month after radiation therapy. Grade 3 toxicities occurred in 1 patient and grade 2 toxicities in another 3 patients. Of the control group, 664 patients qualified for the propensity score analysis; 5 Gy × 5 fractions was significantly superior to 4 Gy × 5 fractions with regard to LPFS (P = .026) but not motor function (P = .51) or OS (P = .82). CONCLUSIONS: Precision radiation therapy with 5 Gy × 5 fractions was well tolerated and effective and appeared superior to 4 Gy × 5 fractions in terms of LPFS. The retrospective nature of the historic control group, which might have led to a hidden selection bias, needs to be considered when interpreting the results.
OBJECTIVE: To investigate precision radiation therapy for metastatic spinal cord compression and compare it to conventional radiation therapy. METHODS AND MATERIALS: In a multicenter phase 2 study, 40 patients received 5 Gy × 5 fractions of precision radiation therapy (38 volume modulated arc therapy, 2 intensity modulated radiation therapy) for metastatic spinal cord compression and were evaluated for local progression-free survival (LPFS), motor function, ambulatory status, sensory function, sphincter dysfunction, pain, distress, overall survival (OS), and toxicity. Maximum spinal cord dose was 101.5% (myelopathy risk, <0.03%) of the prescription dose. Patients were compared with a historical control group conventionally irradiated with 4 Gy × 5 fractions (propensity score analysis). The equivalent dose in 2 Gy-fractions of 5 Gy × 5 fractions is similar to 3 Gy × 10 fractions, which results in better LPFS than 4 Gy × 5 fractions. It was assumed that 5 Gy × 5 fractions is also superior to 4 Gy × 5 fractions for LPFS. (ClinicalTrials.gov-identifier: NCT03070431) RESULTS: Six-month rates of LPFS and OS were 95.0% and 42.6%, respectively. Improvement of motor function occurred in 24 patients (60%). Thirty-three patients (82.5%) were ambulatory after radiation therapy. Eight of 16 patients (50.0%) with sensory deficits improved. Pain and distress relief were reported by 61.9% and 54.2% of patients 1 month after radiation therapy. Grade 3 toxicities occurred in 1 patient and grade 2 toxicities in another 3 patients. Of the control group, 664 patients qualified for the propensity score analysis; 5 Gy × 5 fractions was significantly superior to 4 Gy × 5 fractions with regard to LPFS (P = .026) but not motor function (P = .51) or OS (P = .82). CONCLUSIONS: Precision radiation therapy with 5 Gy × 5 fractions was well tolerated and effective and appeared superior to 4 Gy × 5 fractions in terms of LPFS. The retrospective nature of the historic control group, which might have led to a hidden selection bias, needs to be considered when interpreting the results.
Authors: Dirk Rades; Jon Cacicedo; Darejan Lomidze; Ahmed Al-Salool; Barbara Segedin; Blaz Groselj; Steven E Schild Journal: Cancers (Basel) Date: 2022-05-22 Impact factor: 6.575
Authors: Jacob Y Shin; Noah J Mathis; Neil Ari Wijetunga; Divya Yerramilli; Daniel S Higginson; Adam M Schmitt; Daniel R Gomez; Yoshiya J Yamada; Jonathan T Yang Journal: Adv Radiat Oncol Date: 2022-02-04
Authors: Dirk Rades; Jan Küchler; Lena Graumüller; Abdulkareem Abusamha; Steven E Schild; Jan Gliemroth Journal: Cancers (Basel) Date: 2022-02-28 Impact factor: 6.639
Authors: Giuseppe Roberto Giammalva; Gianluca Ferini; Fabio Torregrossa; Lara Brunasso; Sofia Musso; Umberto Emanuele Benigno; Rosa Maria Gerardi; Lapo Bonosi; Roberta Costanzo; Federica Paolini; Paolo Palmisciano; Giuseppe Emmanuele Umana; Rina Di Bonaventura; Carmelo Lucio Sturiale; Domenico Gerardo Iacopino; Rosario Maugeri Journal: Life (Basel) Date: 2022-04-12
Authors: Dirk Rades; Ahmed Al-Salool; Christian Staackmann; Florian Cremers; Jon Cacicedo; Darejan Lomidze; Barbara Segedin; Blaz Groselj; Natalia Jankarashvili; Antonio J Conde-Moreno; Raquel Ciervide; Charlotte Kristiansen; Steven E Schild Journal: Cancers (Basel) Date: 2022-08-07 Impact factor: 6.575